To Evaluate Sleep Medications, FDA Tests Morning Driving

In considering the safety of sleep medications, the U.S. Food and Drug Administration (FDA) is turning greater attention to the question of drowsy morning driving in people who took sleep medicines like Ambien the night before.

Prior to approving a sleep aid, the FDA tests to see if the drug is safe and effective in helping someone fall asleep, but the agency is now taking a closer look at lingering effects the next day, The New York Times reports. Safety officials are concerned about drivers still under the influence of sleep medications taking to busy roads during morning rush hour, many of them driving with children or co-workers in their cars.

Drivers have long been warned about driving when taking medicines—prescription and over the counter—that can induce drowsiness but most people don’t consider the danger of lingering effects of prescription sleep aids. Last month the FDA rejected Merck’s application for approval of a new sleep drug, suvorexant, in part because some people testing the drug had trouble driving the next morning. According to the Times, four women withdrew from Merck’s driving tests because of excessive drowsiness.

Merck said the FDA indicated it would likely approve suvorexant if the proposed doses were lowered. A number of drug makers are considering lower doses in general and different doses for men and women.

Research has shown that some people react more strongly to drugs than others and drugs can linger longer in some people’s systems, according to the Times. Some sleep medications last longer for women than for men. Earlier this year, the FDA ordered that the dose for all drugs containing zolpidem, the active ingredient in Ambien, be cut in half for women.

Traffic safety experts say that simply testing reaction time behind the wheel is not enough. Alertness is crucial. Drivers still drowsy from the previous night’s sleeping pill can fall asleep behind the wheel, but, experts warn, so can drivers who are drowsy because they didn’t sleep well the night before. There is risk in both sleep medications and insomnia, notes the Times.